Method for plicating and fastening gastric tissue

ABSTRACT

A method of implanting a device to maintain a plication within a hollow organ. The method uses an elongated member having an end effector at its distal end. The end effector has an outer cylinder having at least one opening, and an inner cylinder having at least one opening. The inner cylinder is at least partially disposed within the outer cylinder and the cylinders are rotatable with respect to each other. The end effector is detachable from the elongated member such that it can remain within the body cavity. The method involves the step of inserting the end effector within the organ of a patient such that it is in contact with tissue. The method also involves the step of applying vacuum through the elongated member so as to dispose tissue within the inner cylinder. The method also involves the step of creating a plication by rotating the cylinders with respect to each other. The method also involves the step of detaching the end effector from the elongated member.

FIELD OF THE INVENTION

The present invention relates in general to a bariatric treatment methodand, more particularly, to a method for transorally plicating andfastening areas of gastric tissue to achieve a gastric volume reduction.

BACKGROUND OF THE INVENTION

The percentage of the world's population suffering from morbid obesityis steadily increasing. Severely obese persons are susceptible toincreased risk of heart disease, stroke, diabetes, pulmonary disease,and accidents. Because of the effect of morbid obesity to the life ofthe patient, methods of treating morbid obesity are being researched.

Numerous non-operative therapies for morbid obesity have been tried withvirtually no permanent success. Dietary counseling, behaviormodification, wiring a patient's jaws shut, and pharmacological methodshave all been tried, and failed to correct the condition. Mechanicalapparatuses for insertion into the body through non-surgical means, suchas the use of gastric balloons to fill the stomach have also beenemployed in the treatment of the condition. Such devices cannot beemployed over a long term, however, as they often cause severeirritation, necessitating their periodic removal and hence interruptionof treatment. Thus, the medical community has evolved surgicalapproaches for treatment of morbid obesity.

Most surgical procedures for treatment of morbid obesity may generallybe classified as either being directed toward the prevention ofabsorption of food (malabsorption), or restriction of stomach to makethe patient feel full (gastric restriction) The most commonmalabsorption and gastric restriction technique is the gastric bypass.In variations of this technique, the stomach is horizontally dividedinto two isolated pouches, with the upper pouch having a small foodcapacity. The upper pouch is connected to the small intestine, orjejunum, through a small stoma, which restricts the processing of foodby the greatly reduced useable stomach. Since food bypass much of theintestines, the amount of absorption of food is greatly reduced.

There are many disadvantages to the above procedure. Typically the abovementioned procedure is performed in an open surgical environment.Current minimally invasive techniques are difficult for surgeons tomaster, and have many additional drawbacks. Also, there is a high levelof patient uneasiness with the idea of such a drastic procedure which isnot easily reversible. In addition, all malabsorption techniques carryongoing risks and side effects to the patient, including malnutritionand dumping syndrome.

Consequently, many patients and physicians prefer to undergo a gastricrestriction procedure for the treatment of morbid obesity. One of themost common procedures involves the implantation of an adjustablegastric band. Examples of an adjustable gastric band can be found inU.S. Pat. No. 4,592,339 issued to Kuzmak; RE 36176 issued to Kuzmak;U.S. Pat. No. 5,226,429 issued to Kuzmak; U.S. Pat. No. 6,102,922 issuedto Jacobson and U.S. Pat. No. 5,601,604 issued to Vincent, all of whichare hereby incorporated herein by reference. In accordance with currentpractice, a gastric band is operatively placed to encircle the stomach.This divides the stomach into two parts with a stoma in-between. Anupper portion, or a pouch, which is relatively small, and a lowerportion which is relatively large. The small partitioned portion of thestomach effectively becomes the patients new stomach, requiring verylittle food to make the patient feel fall.

However, patients and physicians are seeking even more less invasiveproducts and procedures for treating morbid obesity.

SUMMARY OF THE INVENTION

A method of implanting a device to maintain a plication within a holloworgan. The method uses an elongated member having an end effector at itsdistal end. The end effector has an outer cylinder having at least oneopening, and an inner cylinder having at least one opening. The innercylinder is at least partially disposed within the outer cylinder andthe cylinders are rotatable with respect to each other. The end effectoris detachable from the elongated member such that it can remain withinthe body cavity. The method involves the step of inserting the endeffector within the organ of a patient such that it is in contact withtissue. The method also involves the step of applying vacuum through theelongated member so as to dispose tissue within the inner cylinder. Themethod also involves the step of creating a plication by rotating thecylinders with respect to each other. The method also involves the stepof detaching the end effector from the elongated member.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims particularly pointing outand distinctly claiming the present invention, it is believed the samewill be better understood by reference to the following description,taken in conjunction with the accompanying drawings, in which:

FIG. 1 is a perspective view of a first embodiment for the tissueplicating device of the present invention;

FIG. 2 is a diagrammatic view of the tissue plication device of FIG. 1,shown pushed into a tissue area in a gastric cavity;

FIG. 3A is a more detailed, perspective view of the distal end of thetissue plicating device of FIG. 1, showing the tip of the device in aninitial, closed position;

FIG. 3B is a more detailed, perspective view of the distal end of thetissue plicating device of FIG. 1, showing the tip of the device in apartially open position;

FIG. 3C is a more detailed, perspective view of the distal end of thetissue plicating device of FIG. 1, showing the tip of the device in afully open, operative position;

FIG. 4 is a diagrammatic view of the tissue plication device of FIG. 1,showing the device creating a fold in an area of tissue;

FIG. 5 is a perspective view of a second embodiment for the foldingmember of the tissue plicating device;

FIG. 6 is an additional perspective view of the folding memberembodiment of FIG. 5, showing the folding member jaws in a fully openposition;

FIG. 7 is a perspective view of a third embodiment for the foldingmember of the present invention;

FIG. 8 is a perspective view of a fourth embodiment for the foldingmember;

FIG. 9 is a perspective view of a fifth embodiment for the foldingmember;

FIG. 10A is a perspective view of a sixth embodiment for the foldingmember showing a retractable jaw of the member in a first, retractedposition;

FIG. 10B is an additional perspective of the sixth folding memberembodiment, showing the retractable jaw in a forward projected position;

FIG. 11 shows an alternative embodiment for the tissue plicating deviceof the present invention, in which the device further comprises a tissuefastening member;

FIG. 12A is a more detailed, perspective view of the fastener embodimentshown in FIG. 11;

FIG. 12B is a top view of the fastener embodiment shown in FIG. 11;

FIG. 12C is an end view of the fastener embodiment shown in FIG. 11;

FIG. 13 is a diagrammatic view of the tissue placation device of FIG.11, showing the device pushed into a tissue wall within a gastriccavity;

FIG. 14 is a diagrammatic view of the tissue plication device of FIG.11, showing the device placing a fastener on a tissue fold;

FIG. 15 is a diagrammatic view similar to FIG. 14, showing the gastriccavity subsequent to folding and placement of a fastening member;

FIG. 16A is a perspective view of an alternative embodiment for a tissueplication fastener;

FIG. 16B is a top view of the alternative fastener shown in FIG. 16A;

FIG. 16C is a side view of the alternative fastener shown in FIG. 16A;

FIG. 16D is an end view of the alternative fastener shown in FIG. 16A;

FIG. 17 is a perspective view of a third embodiment for a tissuefastener in accordance with the present invention;

FIG. 18A is a perspective view of a fourth embodiment for a tissuefastening device;

FIG. 18B is a side view of the tissue fastening device shown in FIG.18A;

FIG. 18C is an end view of the tissue fastening device shown in FIG.18A;

FIG. 19A is a perspective view of a fifth embodiment for a tissuefastening device;

FIG. 19B is a top view of the tissue fastening device shown in FIG. 19A;

FIG. 19C is a side view of the tissue fastening device shown in FIG.19A;

FIG. 20A is a perspective view of a sixth embodiment for a tissuefastening device;

FIG. 20B is a top view of the tissue fastening device shown in FIG. 20A;

FIG. 20C is a side view of the tissue fastening device shown in FIG.20A; and

FIG. 21 is a perspective view of a seventh embodiment for a tissuefastening device of the present invention;

FIG. 22 is a perspective view of an additional embodiment for the tissueplicating implant device of the present invention;

FIG. 23 is a view similar to that shown in FIG. 22 but showing thedevice in its partially deployed position;

FIG. 24 is an exploded view of the embodiment shown in FIG. 22;

FIG. 25A-25D are simplified perspective views of the device shown inFIG. 1 actually acquiring tissue and forming a plication.

DETAILED DESCRIPTION OF THE INVENTION

The present invention pertains to an endoscopic tissue plicating andfastening device for forming tissue folds within a gastric cavity inorder to reduce the volume of the cavity. By creating and securing aplurality of folds along the interior walls of the gastric cavity, thepresent invention reduces the surface area within the cavity, therebyreducing the available food volume in the stomach. The present inventionprovides a simplified tissue plicating procedure in which the tissuefolds are retained by either staples, or absorbable or removable clips,thus enabling the procedure to be easily reversed. Additionally, thepresent invention enables large areas of the stomach cavity to beplicated transorally, thus providing an effective bariatric treatmentwithout the trauma encountered in an open surgery plication procedure.

FIG. 1 illustrates a first embodiment for a tissue plicating device 20of the present invention. Tissue plicating device 20 comprises a foldingmember or end effector 22 connected at the distal end of an elongatedmember such as a flexible endoscope 24. Folding member 22 includes anopen distal end 26 for receiving tissue drawn into the device. Aconnecting member 30 extends between folding member 22 and endoscope 24to securely attach the folding member to the endoscope, so that thefolding member is transferred along with the endoscope during transoralinsertion and removal. Endoscope 24 includes a side port 32 providingaccess to a working channel within the endoscope, as well asvisualization capabilities for guiding device 20 to a desired locationwithin a gastric cavity. Vacuum is provided to folding member 22 fordrawing tissue into the device. In the embodiment shown in FIG. 1,vacuum is provided through a separate vacuum line 34, which extendsalong the exterior length of endoscope 24. Vacuum line 34 connects at aproximal end 36 to a conventional vacuum source (not shown). In analternative embodiment, vacuum can be provided to folding member 22through the working channel of endoscope 24, rather than through aseparate exterior vacuum line.

Control of device 20 is provided through a connection 40 that extendsalong the exterior length of endoscope 24. Control connection 40 isattached at a distal end to folding member 22 for moving the memberbetween an open and closed position, as will be described in more detailbelow. At a proximal end, control connection 40 attaches to a controlassembly (not shown). The control assembly is operated by a surgeon inorder to perform tissue folding and securing procedures. A number ofdifferent types of control assemblies may be utilized to drive thefolding member of the present invention. These assemblies may include apush/pull cabling system, a rotational cable/rod, a hydraulic actuationsystem, or an electromagnetic actuation system.

To form a tissue plication, device 20 is inserted transorally through anesophageal overtube 42 and into a gastric cavity 44, as shown in FIG. 2.Folding member 22 is inserted through the esophagus and into the gastriccavity in an initial, closed position. This closed position allows foreasier transfer into the gastric cavity. Following insertion, endoscope24 is used to visualize the interior of cavity 44 (with a visualizationdevice common to most endoscopes) and select the appropriate locationfor placement of a fold. After the location is determined, the distaltip of folding member 22 is pushed into the tissue wall 46 at theselected location, as shown in FIG. 2. Vacuum is then applied throughvacuum line 34 to draw adjacent tissue into device 20. As vacuum isapplied, the control assembly rotates folding member 22 into an open,tissue receiving position.

FIGS. 3A-3C illustrate the distal end of folding member 22 in greaterdetail as the member is rotated from a closed to an open position. Asshown in the FIGS., folding member 22 comprises a pair of concentriccylinders 50 (inner cylinder), 52 (outer cylinder) each having an opendistal end 26. Lateral slots or apertures 54 extend from open end 26into opposing sides of each of the cylinders 50, 52. One edge of each ofthe slots 54 is angled slightly inwardly, as indicated at 56, in orderto guide tissue into the slots. In an initial position, shown in FIG.3A, cylinders 50, 52 are positioned with the lateral slots 54 of thecylinders offset, thereby substantially closing the sides of the member.To form a tissue fold, one of the cylinders 50, 52 is rotated relativeto the other cylinder to open lateral slots 54, as shown in FIG. 3B. Asthe cylinder is rotated to gradually open folding member 22, vacuum isapplied to the tissue wall through distal opening 26 to pull the tissueinto slots 54. After folding member 22 is fully opened, as shown in FIG.3C, tissue fills slots 54 as the upper and lower layers of the tissueare folded together in a serosa to serosa configuration.

FIG. 4 illustrates device 20 with tissue wall 46 folded into a fullyopen folding member 22 to form a plication 58. After plication 58 isformed, a tissue fastening mechanism such as, for example, a stapler(not shown), is passed through the working channel of endoscope 24 tosecure the plication. Alternatively, the end effector could be detachedfrom the endoscope after the plication is made to secure the tissuetogether. This could be accomplished by any number of means known tothose skilled in the art, such as placing matching detents on thecylinders which latch when the end effector is in its closed position.

After plication 58 is secured, the fastening mechanism is withdrawn, andthe vacuum through line 34 turned off, to release the plication fromfolding member 22. Following release of the plication, cylinders 50, 52are rotated to close folding member 22. Endoscope 24 and folding member22 may then be moved to another location within the gastric cavity toform an additional plication. Once in the new location, vacuum is, againapplied to folding member 22 as the member is rotated open, to drawtissue into a fold within lateral slots 54. After folding, the tissue isagain secured, the vacuum turned off, and folding member 22 rotated to aclosed position. This procedure for forming a tissue plication may berepeated at multiple locations within the gastric cavity until thedesired number of plications have been completed. In a typical bariatricprocedure, it is anticipated that 5 or 6 plications would be formedwithin the gastric cavity to produce approximately a 50% volumereduction. A lesser or greater number of plications may be formed,however, depending upon the particular needs of the patient.

FIGS. 5 and 6 illustrate an alternative embodiment for the foldingmember of the present invention. In this alternative embodiment, thetissue folding member comprises a pair of semi-circular reciprocatingjaws 60 connected at the distal end of endoscope 24 by connecting member30. Jaws 60 are attached together by pivot pins 62 to open and closerelative to a distal opening 64. Each of jaws 60 is operated throughcontrol connection 40 to pivot outwardly relative to the axialcenterline of the folding member. Vacuum is applied to the interior areabetween jaws 60 by vacuum line 34. Jaws 60 are initially in a closedposition during transoral insertion into the gastric cavity. Once in thecavity, the distal edges of jaws 60 are pushed into the tissue wall atthe desired plication location, in a manner similar to that describedabove with respect to the first folding member embodiment. Once jaws 60are lodged in the tissue wall, the vacuum source is turned on, and thejaws are slowly opened to fold the tissue wall into the opening betweenthe jaws. A pair of teeth 66 may be located adjacent the outer edge ofeach jaw 60 for grasping and holding the folding tissue in the jawsuntil the plication is secured and released. After jaws 60 are fullyopened, as shown in FIG. 6, a tissue securing device may be passedthrough the working channel of endoscope 24 to secure the fold.

In an alternative embodiment to that shown in FIGS. 5 and 6, the tissuefolding member may comprise a set of tissue grasping jaws in which onejaw rotates relative to a fixed second jaw. In this embodiment, shown inFIG. 7, the folding member comprises a cylinder 70 with the upperportion cutaway to form a fixed lower jaw 72. Lower jaw 72 extendsaxially from cylinder 70 as a semi-circular distal projection. A mating,semi-circular upper jaw 74 is attached to the folding member by pivotpins 76. Upper jaw 74 extends in a parallel fashion to lower jawextension 72. To form a tissue fold, vacuum is applied through theinterior of cylinder 70 to draw the tissue wall proximally into anopening 78 between jaws 72, 74. As tissue is pulled between the jaws,upper jaw 74 is pivoted away from lower jaw 72, via control connection40, to increase the size of the tissue opening and allow the tissue wallto fold into the opening. After upper jaw 74 is pivoted to a fully openposition, the folded tissue between the jaws is secured by a fasteningdevice passed through endoscope 24. Vacuum is then turned off, and thesecured plication released from the folding member.

FIG. 8 illustrates another alternative embodiment for the folding memberof the present invention. In this embodiment, tissue folding isaccomplished through a cylindrical end piece 80 attached by connectingmember 30 at the distal tip of endoscope 24. End piece 80 includes aside slot 82 that extends proximally from an open distal end 84. Vacuumis applied through the interior of end piece 80 to draw tissue into openend 84 and up into slot 82. As the tissue is pulled into slot 82, thewalls of the tissue are folded together. After the tissue has been fullydrawn up into slot 82, a securing device may be passed through endoscope24 to affix the tissue layers together. Following tissue securement, thevacuum through line 34 is turned off to release the tissue plicationfrom distal end 84.

FIG. 9 shows yet another embodiment for a tissue folding member of thepresent invention, in which the member comprises a cylinder 90 having anopen distal end 92 and a pair of side slot openings 94, 96. In thisembodiment, vacuum is applied through cylinder 90 and open distal end 92to draw tissue into the device. As tissue is pulled into the device, thetissue expands up into side slots 94, 96. As tissue is drawn into sideslots 94, 96 a fold is formed therein. After the tissue as been fullydrawn up into slots 94, 96, a securing device may be passed throughendoscope 24 to affix the tissue layers together. Following tissuesecurement, the vacuum through line 34 is turned off, and the deviceretracted away from the cavity wall in order to release the tissueplication from distal end 92. The folding member embodiments shown inFIGS. 8 and 9 both comprise a fixed cylindrical body for drawing tissueinto the device. Accordingly, these embodiments eliminate the need toextend a control connection 40 to the distal end of the device in orderto operate the folding member.

FIGS. 10A and 10B illustrate an additional embodiment for a tissuefolding member of the present invention. In this embodiment, the foldingmember comprises a cylindrical piece 100 having a first, fixed jaw 102projecting from an open end 104. A second, retractable jaw 106 extendsinto open end 104 on a side opposite fixed jaw 102. To form a tissuefold in this embodiment, the distal tip 107 of the folding member ispushed into the gastric tissue wall at a desired plication location.Second jaw 106 is initially in a retracted position, shown in FIG. 10A,when the folding member is positioned against the tissue wall. Oncetissue contact is made at the desired location, vacuum from line 34 isapplied through the interior of cylinder 100 to pull tissue onto firstjaw 102. After the tissue wall is engaged with first jaw 102, second jaw106 is moved distally, substantially parallel to first jaw 102, to pullthe tissue outward and fold the tissue over the first jaw. The tip ofsecond jaw 106 is radii smooth, as indicated by reference numeral 108,to facilitate the second jaw sliding over the tissue. After second jaw106 is fully extended, as shown in FIG. 10B, a fastening mechanism ispassed through the interior of cylinder 100 to fasten the plication.After fastening, the vacuum through cylinder 100 is turned off, and jaw106 retracted back into cylinder 100. The folding member may then bemoved to a new tissue location to form additional plications, or removedfrom the patient.

In alternative embodiments for gastric plicating device 20, the devicefurther comprises a fastening means for securing the tissue plicationsubsequent to tissue folding. Use of a fastening means on device 20eliminates the need to pass a separate tissue fastening mechanismthrough endoscope 24 after folding in order to secure the plication. Inthe embodiment shown in FIG. 11, a fastening member 110 is disposedadjacent the distal end of the device for transfer from the device to aplication after folding. Fastening member 110 is held sufficientlysecure on device 20 to be passed along with endoscope 24 and foldingmember 22 into the gastric cavity, yet is removable through controlconnection 40 at the end of a tissue folding procedure to secure aplication. In the embodiment shown in FIG. 11, the fastening member is awire clip 110 which is retained on connecting member 30 just proximal ofthe tissue folding slots 54 in folding member 22. Wire clip 110 iscontoured to surround the perimeter of connecting member 30 and foldingmember 22 and be retained thereon during device insertion.

As shown in greater detail in FIGS. 12A-12C, wire clip 110 comprises acontinuous length of thin gauge wire. The proximal end of clip 110 isshaped on opposing sides in a spring form, indicated by referencenumeral 112, to assist in generating sufficient force to clamp onto thefolded tissue. From spring form 112, the wire is shaped into a pair oftelescoping jaws 114, 116, as shown in FIG. 12B. Jaws 114, 116 extenddistally from spring forms 112 in a parallel fashion to slide along theupper and lower surfaces of a tissue fold. The distal tips 118 of jaws114, 116 may flare outwardly from the axial centerline of clip 110 tofacilitate lead-in of the clip onto a tissue fold. As shown in FIG. 12C,clip 110 has a substantially circular cross-section to conform to theshape of connecting member 30 to aid in retaining the clip on thefolding member during the transoral insertion of device 20. After tissuefolding, control connection 40 engages clip 110 to release the clip fromfolding member 22, and slide the clip onto the tissue fold.

FIG. 13 illustrates device 20 with wire clip 110 disposed thereonengaging a gastric tissue wall prior to folding. As shown in FIG. 13,clip 110 is carried on connecting member 30 as device 20 is insertedinto gastric cavity 44 and pushed into tissue wall 46 at a desiredplication location. FIG. 14 similarly illustrates gastric cavity 44 asvacuum is applied through folding member 22 to draw tissue wall 46 intoa fold. As the tissue fold is formed, jaws 114, 116 of clip 110 expandand move over folding member 22 to initially engage the tissue fold.After upper and lower layers of tissue wall 46 are folded togetherwithin slots 54, clip 110 is released from folding member 22 so thatjaws 114, 116 clamp down on plication 58. Jaws 114, 116 clamp ontoplication 58 due to the energy stored in spring forms 112. After clip110 engages plication 58, the vacuum to folding member 22 is turned off,and the remainder of device 20 moved away from the plication location,leaving the fastened plication as shown in FIG. 15.

FIGS. 16A-16D illustrate an alternative embodiment for a tissue fastenerusable with folding member 22 of the invention. In this embodiment, thefastener comprises a continuous wire clip 120 formed into a pair ofparallel extending jaws 122, 124 that engage a tissue fold. Jaws 122,124 each comprise a pair of evenly spaced wire lengths that are bent at180° angles at the proximal ends of the clip, as indicated by referencenumeral 126. The distal ends of jaws 122, 124 flare outwardly, asindicated at 128, to enhance lead-in of the clip onto the tissue fold.Clip 120 also comprises one or more wire shapes for preventing slippageof the clip along the tissue fold. As shown in FIG. 16C, these wireshapes may comprise indentations or “teeth” 130 placed along the lengthof either of jaws 122 or 124. As shown in FIG. 16D, clip 120 has asubstantially circular cross-section that follows the contour ofconnecting member 30 and folding member 22 to retain the clip on device20 until released onto a tissue fold through control connection 40.

FIG. 17 illustrates a third embodiment for a tissue fastener inaccordance with the present invention. As shown in FIG. 17, in thisembodiment the tissue fastener comprises a tubular-shaped clip 132. Clip132 has an inner diameter that is sized to contour the outer perimeterof connecting member 30 to retain the clip thereon until released onto afold. Clip 132 has an open distal end 134 for engaging a tissue fold. Apair of semi-circular jaws 136, 140 extends along the axial length ofclip 132 for engaging a tissue fold as the clip is transferred onto thefold through control connection 40. Jaws 136, 140 each have a roundeddistal end for facilitating transfer of clip 132 onto the tissue fold. Aplurality of teeth, indicated by reference numeral 142, extend from theinwardly facing edges of jaws 136, 140 to grasp and hold tissue withinthe clip, thereby preventing the clip from dislodging from the tissuefold after fastening. Clip 132 can be manufactured from either a plasticor a metallic material. Clip 132 can also be made from absorbablematerial where it will dissolve away after three weeks and pass throughthe digestive tract safely. It could be made of laminate construction assmall particles of absorbable material would pass and no large parts cancome off all at once.

FIGS. 18A-18C illustrate another alternative embodiment for a tissuefastening member of the present invention. In this embodiment, afastener 150 comprises a proximal frame area 152 having a cylindricalcontour for fitting about the perimeter of connecting member 30. Thedistal end of fastener 150 comprises a pair of semicircular, tissueengaging jaws 154, 156. Jaws 154, 156 each have a tapered distal edge,as indicated at 158, to provide a lead-in for engaging a tissue fold. Apair of holes 160 are located in a midsection of fastener 150, betweenproximal frame area 152 and jaws 154, 156. Holes 160 extendperpendicular to the axial length of the fastener. A suture 162 passesthrough holes 160 and then proximally through openings 164 in frame area152. After jaws 154, 156 engage a tissue fold, suture 162 is tightenedthrough holes 160 and openings 164 to pull jaws 154, 156 inwardlytowards the tissue fold. As jaws 154, 156 are pulled inwardly, the jawsdeflect laterally along the upper and lower surfaces of the fold,clamping the fold between the jaws. A suture lock 166 is placed onsuture 162 after tissue fastening, to prevent the suture from relaxingand releasing the tissue fold from jaws 154, 156.

FIGS. 19A-19C illustrate yet another alternative embodiment for thefastening means of the present invention. In FIGS. 19A-19C, a fastener170 is shown having a proximal frame area 172 and a distal clamping area174. Proximal frame area 172 has a cylindrical cross-section forretaining fastener 170 about the perimeter of connecting member 30.Clamping area 174 comprises a pair of semicircular, tissue engaging jaws176, 180. Jaws 176, 180 each have a tapered distal edge, as indicated at182, for ease in engaging a tissue fold. Additionally, rows of tissuegrasping teeth 184 extend along the inward facing edges of jaws 176, 180to prevent the fastener from slipping along the tissue fold. A pair ofholes 186 is located in a midsection of fastener 170, between frame area172 and clamping area 174. Holes 186 extend perpendicular to the axiallength of the fastener. In a manner similar to the embodiment shown inFIGS. 18A-18C, a suture 190 passes through holes 186 and openings 188 toclamp jaws 176, 180 inwardly onto a tissue fold. A plurality of notches,indicated by reference numeral 192, extend axially along the distal endof jaws 176, 180. Notches 192 allow jaws 176, 180 to flatten out alongthe surface of the tissue fold when tightened by suture 190. Notches 192also facilitate the application of an even clamping force to the fold. Asuture lock 194 is placed on suture 190 to prevent the suture fromrelaxing and releasing the tissue fold from jaws 176, 180. An additionalplurality of openings 196 extend through clamping area 174 to enablefastener 170 to be stitched closed from the inside of the cavity, inorder to further secure the tissue fold.

FIGS. 20A-20C illustrate another alternative embodiment for the tissuefastening means of the present invention. In this embodiment, a fastener200 comprises a ring 202 and a pair of telescoping jaws 204, 206extending distally from the ring. The distal edges of jaws 204, 206 aretapered, as indicated at 208, to provide a lead-in edge for fastener 200to roll over a tissue fold. The first jaw 204 comprises a cutout 210that mirrors the outer profile of the second jaw 206 to enable the jawsto interdigitate when the jaws are clamped together on a tissue fold.Jaws 204, 206 are preloaded towards an axial centerline 212 of thefastener to compress and hold the folded tissue as the fastener is drawnover the fold.

FIG. 21 illustrates yet another clip 220 for fastening a tissue fold.Clip 220 comprises a proximal spring end 222. A pair of jaws 224, 226project forward from spring end 222 to a rounded distal end 230. Distalend 230 is rounded to facilitate placement of clip 220 on a tissue fold.Spring end 222 serves to clamp jaws 224, 226 on a tissue fold andinhibit the clip from slipping along the fold. To further prevent clip220 from releasing from a tissue fold, a plurality of serrated teeth 232extend substantially along the length of jaws 224, 226. Teeth 232 may beangled proximally to prevent clip 220 from being removed from the tissuefold. Alternatively, teeth 232 may be angled distally to enable clip 220to be removed from a fold provided tissue has not grown over the clip.In the clip depicted in FIG. 21, teeth 232 are placed at a 45 degreeangle to hold tissue securely, yet enable subsequent removal of the clipshould such removal be required.

Yet another embodiment of the present invention is described in FIGS.22-24 which shows tissue plicating device 320. Device 320 is similar todevice 20 described above, however the end effector 323 of device 320 isdetachable from the distal end 232 of endoscope 324. After the tissue isacquired and pinched within end effector 323 (such as described in FIG.25 below), a push rod within the endoscope (not shown) pushes on collar350, moving the end effector 323 distally so as to expose legs 360. Legs360 are biased outwardly such that as they move distally the removetheir grip on the end effector 323, thereby releasing end effector 323from attachment with the scope 324.

How device 20 operates within the body can be described by looking atFIGS. 25A through 25B. As shown in FIGS. 25A and 25B the end effector 22has been placed within the body in its closed position and is placedadjacent to tissue 400. Vacuum is the applied to draw the tissue withinthe closed cylinder of end effector 22. Thereafter, the cylinders arerotated as shown in FIGS. 25C and 25D. Now, a clip or other fasteningmeans such as those described above can be applied to maintain theplication. For the embodiment shown in FIG. 22, the device can now berotated even further to pinch the tissue between the cylinders tomaintain the plication. In addition the Figures show the cylindershaving gripping means 17 on either or both cylinders to better griptissue therein.

The present invention has been described above with respect to its useduring a transoral plication procedure. However, it should be understoodthat the device is also adaptable for use during laparoscopic and opentissue plication procedures without departing from the scope of theinvention. Additionally, it is intended that each of the embodimentsdescribed above for the folding member be interchangeable and useablewith each of the tissue fastening embodiments during a tissue plicationprocedure.

It is also to be understood that the above described might be sterilizedand reused. There are any number of sterilization methods known to thoseskilled in the art including: gamma radiation and ETO.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the spirit and scope of the appendedclaims.

1. A method of implanting a device to maintain a plication within ahollow organ, said method comprising the steps of: a. providing anelongated member having an end effector at a distal end, said endeffector comprising an outer cylinder having at least one opening in acylindrical wall thereof, and an inner cylinder having at least oneopening in a cylindrical wall thereof, said inner cylinder is at leastpartially disposed within said outer cylinder, wherein said cylindersare rotatable with respect to each other to pinch the tissue between thecylinders to maintain the plication and wherein said end effector isdetachable from said elongated member such that it can remain withinsaid body cavity; b. inserting said end effector within the organ of apatient such that it is in contact with tissue; c. applying vacuumthrough said elongated member so as to dispose tissue within said innercylinder; d. acquiring and pinching tissue within the end effector byrotating said cylinders with respect to each other; and e. detachingsaid end effector from said elongated member.
 2. The method of claim 1further comprising the step of inserting a visualization means withinsaid organ.
 3. The method of claim 1 further comprising the step ofsterilizing said device after step (f).
 4. A method of implanting adevice to maintain a plication within a hollow organ, said methodcomprising the steps of: a. providing an elongated member having an endeffector at a distal end, said end effector comprising an outer cylinderhaving at least one opening in a cylindrical wall thereof, and an innercylinder having at least one opening in a cylindrical wall thereof, saidinner cylinder is at least partially disposed within said outercylinder, wherein said cylinders are rotatable with respect to eachother to pinch the tissue between the cylinders to maintain theplication and wherein said end effector is detachable from saidelongated member such that it can remain within said body cavity; b.rotating said cylinders with respect to each other such that saidapertures at least partially overlap; c. inserting said end effectorwithin the organ of a patient such that it is in contact with tissue; d.applying vacuum through said elongated member so as to dispose tissuewithin said inner cylinder; e. acquiring and pinching tissue within theend effector by rotating said cylinders with respect to each other; andf. detaching said end effector from said elongated member.
 5. The methodof claim 4 further comprising the step of inserting a visualizationmeans within said organ.
 6. The method of claim 4 further comprising thestep of sterilizing said device after step (f).